Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1340](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1340) → DYB — Introducer, Catheter

# DYB · Introducer, Catheter

_Cardiovascular · 21 CFR 870.1340 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/DYB

## Overview

- **Product Code:** DYB
- **Device Name:** Introducer, Catheter
- **Regulation:** [21 CFR 870.1340](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1340)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 702)

Showing 20 most recent of 702 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K261492](/device/K261492.md) | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | Jun 5, 2026 | SESE |
| [K260606](/device/K260606.md) | Echo Large Bore Introducer Sheath | Echo Medical, LLC | Apr 29, 2026 | SESE |
| [K254248](/device/K254248.md) | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | Apr 23, 2026 | SESE |
| [K254279](/device/K254279.md) | Edwards eSheath+ introducer set | Edwards Lifesciences | Apr 17, 2026 | SESE |
| [K260091](/device/K260091.md) | Aventus Introducer Sheath | Inquis Medical | Apr 13, 2026 | SESE |
| [K260839](/device/K260839.md) | Protaryx Transseptal  Puncture Device (PTX2-001) | Protaryx Medical, Inc. | Apr 10, 2026 | SESE |
| [K260942](/device/K260942.md) | AuST Steerable Sheath | CenterPoint Systems, LLC | Apr 7, 2026 | SESE |
| [K260459](/device/K260459.md) | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | Apr 6, 2026 | SESE |
| [K260626](/device/K260626.md) | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | Mar 26, 2026 | SESE |
| [K260163](/device/K260163.md) | AuST CSP Introducer | CenterPoint Systems, LLC | Feb 19, 2026 | SESE |
| [K254236](/device/K254236.md) | Peel-Away Introducer Sheath | VascuTech Medical, LLC | Feb 9, 2026 | SESE |
| [K253652](/device/K253652.md) | Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC | Jan 22, 2026 | SESE |
| [K252508](/device/K252508.md) | Intri26 Introducer Sheath | Inari Medical, Inc. | Dec 17, 2025 | SESE |
| [K253741](/device/K253741.md) | V•Stick™ Vascular Access Set | Argon Medical Devices, Inc. | Dec 15, 2025 | SESE |
| [K252309](/device/K252309.md) | PerQseal Introducers | Vivasure Medical Limited | Oct 23, 2025 | SESE |
| [K251838](/device/K251838.md) | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | Oct 21, 2025 | SESE |
| [K252766](/device/K252766.md) | 14Fr Low Profile Introducer Kit | Abiomed, Inc. | Oct 8, 2025 | SESE |
| [K252441](/device/K252441.md) | Primero Safe Access System | South53, LLC | Sep 29, 2025 | SESE |
| [K252227](/device/K252227.md) | Pounce(TM) Sheath | Surmodics,Inc. | Sep 24, 2025 | SESE |
| [K252027](/device/K252027.md) | Vertex(TM) Catheter | Jupiter Endovascular | Sep 12, 2025 | SESE |

## Top Applicants

- St Jude Medical — 21 clearances
- Cordis Corp. — 19 clearances
- Terumo Medical Corp. — 19 clearances
- Daig Corp. — 18 clearances
- Merit Medical Systems, Inc. — 18 clearances

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**Source:** [https://fda.innolitics.com/productcode/DYB](https://fda.innolitics.com/productcode/DYB)

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**Cite:** Innolitics at https://innolitics.com